Efficacy of a Computerized Program of Cognitive Rehabilitation of Attention in People With Acquired Brain Injury (ABI): Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Trail Making Test (TMT A-B): changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention
研究概览
简要总结
Acquired Brain Injury (ABI) is a sudden lesion in the brain, not congenital or perinatal,caused by various pathologies.According to the National Statistics Institute,in Spain 78% of people suffering from ABI are a result of stroke,and 22% due to Traumatic Brain Injuries (TBIs) and other causes.The ABI is in most cases with problems of cognitive,physical,emotional,social,family and work.Of all these problems,attentional alterations are one of the most frequent and disabling for these participants,with a prevalence of 30-62%.However,there are currently no specific programs for the rehabilitation of attentional processes in people with ABI in Spain.So recently,a program focused on the rehabilitation of NeuronUp APT attentional processes has been developed,based on the theoretical model of Sohlberg and Mateer,which considers attention as a multidimensional cognitive function that is hierarchically organized.This program includes a large group of rehabilitation activities in contexts similar to those of daily life.Objectives:1)Evaluate the effectiveness of the NeuronUp APT attentional training program for the improvement of the attention problems presented by participants with ABI;2)determine whether the improvement of attention problems in participants with ABI causes changes in their functioning emotional and quality of life and 3)determine whether the improvement of the attention problems in participants with ABI causes changes in the functionality of the participants and, consequently, in the activities of their daily lives.Method:This is a randomized clinical trial, 46 participants with ABI between the ages of 18-65 will be recruited; 23 participants will be assigned to the experimental group (integral rehabilitation+NeuronUp APT) and the other 23 to the control group (integral rehabilitation) randomly,using a simple randomization method.Both groups will be evaluated before the start of the intervention, after the end of the intervention and 6 months after the intervention, thus collecting sociodemographic information,clinical characteristics of the disease, cognitive screening measures,emotional functioning test,functional and quality of life.Conclusions:It is hoped to achieve a transfer of the gains obtained,through the training of the attention through the NeuronUp APT rehabilitation program,to other aspects of cognitive,emotional functioning and quality of life.It is also expected that these people improve their attention problems in their daily lives.
详细描述
General objectives
1)Evaluate the effectiveness of the NeuronUp APT attention training program for the improvement of the attention problems presented by participants with ABI. 2)Determine whether the improvement of the attention problems in the group of participants with ABI, leads to an improvement in the cognitive performance of these participants in the other areas of cognitive functioning. 3)Determine if the improvement of attention problems in participants with ABI, causes changes in their emotional functioning and quality of life. 4)Determine if the improvement of the attention problems in participants with ABI, causes changes in the functionality of the participants and, consequently, in the activities of their daily life.
Specific objectives
1)Determine if there are significant differences between the groups in the scores of the attention tests over time. 2)Determine if there are significant differences between the groups in the scores of the neuropsychological tests that measure memory, executive functions and language over time. 3)Determine if there are significant differences between the groups in the scores of the scale of attention problems in daily life after the intervention.4)Determine if there are significant differences between the groups in the scores of the scale of quality of life over time. 5)Determine if there are significant differences between the groups in the scores of the scales of emotional functioning over time. 6)Determine if there are significant differences between the groups in the scores of the functional functioning scales over time.
Hypothesis
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be between 18 and 65 years old at the time of the intervention; 2) enter the Acquired Brain Injury Unit of the Aita Menni hospital with a diagnosis of ABI;3) have been hospitalized in the Aita Menni unit for at least 3 weeks;4) the patient must know how to read and write; 5) obtain a score below the 10th percentile in at least one of the attention tests in the screening phase and 6) not present post traumatic amnesia at the start of the study, in the case of patients with TBI.
排除标准
- •Present severe behavioral alterations; 2) have a previous history of neurological disease, psychiatric disorders, intellectual disability, learning disorders and / or substance abuse; 3) have a diagnosis of aphasia; 4) present a score less than or equal 23 in the Mini-mental State Examination (MMSE) and 5) present severe motor or sensory problems that may limit the performance of the tests and the attention rehabilitation program.
结局指标
主要结局
Trail Making Test (TMT A-B): changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention
时间窗: Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention
The test is used to evaluate attention, psychomotor speed, cognitive flexibility, visual search and executive functions.
Symbol and digit test (SDMT): changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention
时间窗: Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention
It is a test that involves the conversion of geometric designs into written and / or spoken numerical responses. The test is applied from 8 years to 78 and can be individually or collectively. Because the test consists of geometric figures and numbers, and these are universal symbols of written language, the SDMT test is relatively free of cultural and idiomatic factors and can be applied in different countries and languages.
Attention Test D2: changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention
时间窗: Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention
This test is a cancellation task that evaluates the basic processes of selective attention and mental concentration. This instrument also reflects three components of attentional behavior: the speed or amount of work, the quality of work and the relationship between speed and accuracy of attention.
Short attention test (BTA): changes in the measure before the intervention (pre-intervention), after the intervention (post-intervention) and six months after the intervention
时间窗: Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention
The test is used as a measure of divided attention. It can be used in people between 17 and 82 years, it is of individual application with an approximate duration of 10 minutes.
PASAT test: changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention
时间窗: Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention
This test is a measure of cognitive function that evaluates the speed and flexibility of the processing of auditory information, as well as the ability to calculate.
Bells Test: changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention
时间窗: Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention
The Bells Test is used to detect visual inattention in children and adults and it consists of a 21.5 × 28 cm sheet of paper on which seven lines of 35 distractor figures (e.g., bird, key, apple, mushroom, car) and five target figures (bells) are presented. The target figures are arranged so that five of each appears in seven equal columns on the page
Minimental State Examination (MMSE): changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention
时间窗: Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention
MMSE is a short and quantitative measurement that can be used to detect cognitive deficits, to assess its severity at a given time, to follow the course of cognitive changes over time and to evaluate the response to a treatment. Several investigations have shown that the MMSE is a reliable and valid instrument in different patient samples and the general population.The scores of MMSE are 0 to 30. In this study the participants need to have a score major 23 for participate. Because, if the score is less or equal 23 in this test, the participant can have an important cognitive deficits.
Test of Colors and Words (Stroop Test): changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention
时间窗: Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention
It provides information on the inhibitory capacity of the subject and its resistance to stimulus interference.
次要结局
- Test of the complex figure of Rey: changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention(Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention)
- Disability Rating Scale (DRS): changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention(Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention)
- Hopkins Verbal Learning Test - Revised (HVLT-R): changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention(Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention)
- Quality of life scale (SF-36): changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention(Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention)
- Boston Denomination Test (BNT): changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention(Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention)
- European Brain Injury Questionnaire (EBIQ): changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention(Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention)
- Questionnaire of attention problems: changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention(Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention)
- Moss Attention Rating Scale (MARS): changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention(Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention)
- Patient Health Questionnaire (PHQ-9): changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention(Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention)
- Life Satisfaction Scale (SWLS): changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention(Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention)
- Modified test of classification of Wisconsin cards (M-WCST): changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention(Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention)
- Phonological and Semantic Verbal Fluency Test: changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention(Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention)
- Generalized Anxiety Disorders Scale (GAD-7): changes in the measure before the intervention (pre-intervention),after the intervention (post-intervention) and six months after the intervention(Pre-intervention, post-intervention (immediately after the intervention) and six months after post-intervention)
研究者
Juan Carlos Arango Lasprilla
Neuropsychologist- Researcher
Ikerbasque - Basque Foundation for Science